Category: vaccine trials

Previously unseen details of a medical trial by Glaxo in 1974 at a Cork mother and baby home have generated a whole new series of questions for the nuns and the companies involved.

For almost two decades, the public has been drip-fed revelations about medical testing by British pharmaceutical companies on children in care in Ireland.

These tests involved the trialling of various vaccine combinations by predecessor companies of pharmaceutical giant GlaxoSmithKline (GSK) — Glaxo Laboratories and Burroughs Wellcome. These revelations generated more questions than answers — answers it is hoped the Mother and Baby Homes Commission can provide.

However, it has now emerged thashoot Glaxo Laboratories was also trialling other products on children here — namely lactose and baby formulas.

This occurred in 1974 in the Bessborough Mother and Baby Home in Cork and had never been made public. Once again, the revelation has generated lots of questions but few answers.

A trial sheet obtained by the Irish Examiner reveals that Glaxo Laboratories carried out a “clinical acceptability and safety trial” of “Golden Ostermilk and Lactose”, while a separate trial sheet reveals a trial of “overseas milk powders (by 0111)”.

The “clinician responsible” for the tests was Eithne Conlon — a local Cork GP who worked with the institution for many years.

Other “abnormal conditions” were also noted. These included excessive crying, irritability, napkin rash, thrush, and others.

The latter trial sheet was contained in the records of Breda Bonass, who had sought information on her medical history from Tusla under Freedom of Information.

The former only came to light when Ms Bonass sought further information from Tusla.

However, this only confused matters further as the trial sheet for “Golden Ostermilk and Lactose” was found in the antenatal records of other women — and all contain identical details including patient numbers — something which the FOI officer told Ms Bonass was “perplexing”.

“In the majority of cases where this record was present the record was glued to another copy of the same record [front to front] and details about the respective baby’s feeding schedules, types of formula given, reactions to feeds, etc, were hand written on this paper,” said the FOI officer.

“When I pried the two sheets apart I noticed that these trial sheets all contained the exact same patient and trial numbers and identifying details as the trial sheet located in your file.”

Ms Bonass went to the religious order which ran Bessborough — the Sisters of the Sacred Hearts of Jesus and Mary — and GSK looking answers.

The nuns responded via their solicitors, telling her they no longer held the records nor had any access to them and that she should go to Tusla.

GSK’s UK data protection section informed her that the data had been “destroyed” as the “retention period has already expired some years ago”.

The Irish Examiner contacted GSK in an effort to get answers as to why this trial was carried out in Ireland, how many children it involved and if consent was sought.

It responded by saying it was “unable to locate any records relating to a 1974 study” but that it had located records relating to a trial from 1967.

“The assumption therefore would be that the 1974 study’s purpose was to compare current milk powder with a newer formulation. The records contain no names or information about the children involved,” said GSK in a statement.

It had no documentation to explain why Ireland was chosen as a location, but that the 1967 trial was also carried out in the UK, Kenya, Argentina, Malaysia, “and probably more”.

With regard to the consent of mothers, GSK said that, due to the fact that it had no records, it could not confirm who gave consent but that its assumption was that it would have been “those Sisters running the homes as the legal guardians”.

Obtaining consent would been left to the doctor conducting the trial.

The company said that, to the best of its knowledge, no financial remuneration would have been provided to the Order for allowing children in its care to be used for the trial.

GSK said the identical sheets were probably blank forms or templates and that the information entered “appear to be codes, possibly relating to a spreadsheet collating all responses”.

It also confirmed that this was the first time it was made aware of this study and that it had not been asked to disclose it in any official capacity, “as this is clearly outside of the current Commission’s [Into Mother and Baby Homes] vaccines inquiry”.

That, of course, is technically correct. The Commission is only tasked with examining vaccine trials carried out by GSK legacy companies. This latest revelation confirms that it wasn’t just vaccines that were being tested on children in care here.

The involvement of Burroughs Wellcome and Glaxo Laboratories in trials on children in Mother and Baby Homes and other institutions is worth repeating.

It’s been a long tale which saw a previous State inquiry —the Commission to Inquire into Child Abuse (CICA) in 2000 — try and fail to fully investigate the matter.

Before that inquiry was halted following a Supreme Court ruling in 2002, GSK had confirmed just three vaccine trials in the 1960s and 1970s involving more than 250 children.

In 2011, in a response to an RTÉ investigation, it acknowledged a fourth trial but stated that this was the only other clinical trial sponsored by Wellcome using children in institutions in Ireland.

However, in 2014, documents uncovered by Michael Dwyer of UCC’s School of History revealed a fifth trial of a measles vaccine on 34 children took place in 1965.

It was carried out by Irene Hillary and Patrick Meenan of UCD’s microbiology department and AJ Beale of Glaxo Laboratories. The UCD academics (both now deceased) were also involved in the first two vaccine trials also.

Earlier that year, Dr Dwyer also discovered evidence that Wellcome had carried out vaccine trials on more than 2,000 Irish children in 24 residential institutions between 1930 and 1935.

Despite this, the Inter-Departmental Group on Mother and Baby Homes published in 2014 only referred to three vaccine trials. It also failed to mention a 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough Mother and Baby Home in Cork.

Questions around the involvement of British pharmaceutical companies in vaccine trials in Ireland have been popping up in the media for almost three decades now.

They first hit the headlines in the 1990s, but it wasn’t until 1997 that then health minister Brian Lenihan gave an undertaking that the matter would be examined.

This resulted in the Kiely Report in 2000, by Jim Kiely, chief medical officer of the Department of Health, which confirmed three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation.

The i nstitutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children).

Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diphtheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Prof Hillary and Prof Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna.

A total of 65 children living at home in Dublin also received the vaccine.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report in 2000 concluded that, given the conditions which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“We are indebted to the medical officers in charge of the children’s homes for permission to carry out this investigation on infants under their care,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of CICA.

This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002.

It obtained documentation from GSK — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

It also sought records from a range of religious orders who were caring for the children used in the trials.

In November of last year, the Irish Examiner revealed that the files of vaccine trial victims from Bessborough involved in the 1960/61 4-in-1 vaccine were altered just weeks after the CICA sought discovery of records from the Sisters of the Sacred Hearts of Jesus and Mary.

The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.”

The changes made to files Nos 5, 8, 11, 12, and 15-20 are then detailed.

The changes include:

The alteration of discharge dates of mothers (by a period of one year and two years):

The changing of discharge dates of children;

The changing of admission dates of mothers;

The alteration of the age of a mother (by two years);

The alteration of dates of adoption;

The changing of baptism dates and location of baptism;

The insertion of certain named locations and information into admission books.

In a series of statements, the order said it wished to “categorically state that no documents were altered”.

“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer. This is entirely untrue; and we will continue to deal directly with the official commission on all such matters,” said a statement.

This document listing the changes was discovered in the Bessborough archive handed over to the HSE by the nuns in 2011.

It wasn’t discovered until 2016 — some 13 years after CICA’s investigation into the vaccine trials was suspended.

This occurred after the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials and when the the Government declined to appeal this decision, the work of the Vaccines Module ceased in November 2003.

However, at the time, many people believed there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement in 2011, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

GSK stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

Then, in 2014, the Irish Examiner revealed a fifth trial also occurred during this period.

An article in The Lancet medical journal in August 1965, discovered by Dr Dwyer confirms that Glaxo Laboratories Ltd carried out another measles vaccine trial on 34 children aged between eight months and just over two years.

The trial was carried out by Prof Hillary and Prof Meenan and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial.

The report does not mention an institution. However, it makes reference to the fact that the reaction to the vaccine were monitored by “the adults looking after the children”.

It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

However, in response, GSK disagreed that these references amounted to evidence that the trial was carried out on children in care.

The pharmaceutical giant pointed out that, in other papers by the same investigator, it was stated explicitly that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA at the time.

So, three years on, we now know that it wasn’t just vaccines that were being tested on children in Ireland’s Mother and Baby Homes.

Now, we know that clinical acceptability and safety trials of lactose, Golden Ostermilk and “overseas baby powders” were being trialled in at least one Mother and Baby Home.

Can and will the commission examine this latest development? Why was a British company testing such products in Ireland?

Were religious orders benefiting financially by allowing children in their care to be involved in such trials? Was the consent of mothers obtained, or was it even sought?

The Mother and Baby Homes Commission said it will investigate all aspects of living conditions and care arrangements at Bessboro.

One of the victims of the Bessborough vaccine trial is to make a formal Garda complaint after it emerged files were altered in 2002.

On Tuesday, the Irish Examiner revealed the files of mothers and children used in the 1960/61 4-in-1 vaccine trial were altered in 2002 — just weeks after the Commission to Inquire into Child Abuse sought discovery of records from the religious order running the home.

Mari Steed was born in Bessborough in 1960 and subsequently adopted in the US. Her natural mother’s file is one of those listed as having been changed. She plans to make a formal complaint to the gardaí and Data Protection Commissioner.

“Now that it’s been confirmed the information in my file has been altered, I feel I have an obligation to make both a Garda and data protection complaint. How many other files, not even relevant to the vaccine trials, may have been altered? People have a right to know this. I am awaiting legal advice on jurisdiction for the Garda filing and then will make both complaints as soon as possible,” she said.

Ms Steed also said Tusla, which now holds the records, had “an ethical, moral, and public interest” in contacting all of the people it can confirm were part of a trial.

The Irish Examiner put a series of questions to the Sisters of the Sacred Hearts of Jesus and Mary in relation to the document. It declined to answer any of them.

A statement from Ruairí Ó Catháin solicitors, representing the order, stated it had “no immediate knowledge of any specific event” concerning alterations made to records.

In a separate statement, the order said it wished to “categorically state that no documents were altered” and that it would deal with the Mother and Baby Homes Commission of Investigation on all such matters.

Material obtained under Freedom of Information shows that changes were made to the records of mothers and children used in the 1960/61 4-in-1 vaccine trials.

The Commission to Inquire into Child Abuse (CICA) had sought discovery of the records from the Sisters of the Sacred Heart of Jesus and Mary on July 22, 2002. An affidavit was sworn on October 3, 2002, and on a number of later dates in 2002 and 2003.

The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.” The changes made to files Nos 5, 8, 11, 12, and 15 to 20 are then detailed.

The changes include:

The alteration of discharge dates of mothers (by a period of one year and two years);

The changing of discharge dates of children;

The changing of admission dates of mothers;

The alteration of the age of a mother (by two years);

The alteration of dates of adoption;

The changing of baptism dates and location of baptism;

The insertion of certain named locations and information into admission books.

The Tuam mother and baby home should not be treated as an individual scandal, but as part of a national trafficking network that commodified people, says Conall Ó Fátharta.

The women and children in Bessborough’s care were ‘considered little more than a commodity for trade amongst religious orders’.

“This may prove to be a scandal that dwarfs other, more recent issues with the Church and State…”

There’s that word, “scandal”, again. As a nation, we don’t tire of hearing it.

That time it was used by senior management in the HSE, in 2012, in relation to the contents of an archive of the Tuam mother and baby home, two years before the Tuam babies scandal broke. It wasn’t the first time the word was used in relation to mother and baby homes and the horrors they hold.

Seventy years earlier, the same word was used by parliamentary secretary to the then minister for local government and public health, Dr Con Ward, in relation to an 82% infant death rate at the Bessborough Mother and Baby Home. That rate had been reported to state inspectors.

Two things are instructive. Not only has the State known for decades about this issue, but it is impossible to look at Tuam, or mother and baby homes, in isolation. Yet, that is exactly how this issue is playing out.

First, there is a scandal. Then there is an outcry. Then, there is an inquiry, but a limited one.

Focus on the narrow and ignore the broader picture. It’s a well-worn path.

Instead of examining the bigger picture of how unmarried women and children were treated in a sprawling network of interlinking institutions, private agencies and individuals, we compartmentalise.

We treat the Magdalene Laundries, and then the mother and baby homes, as if they are distinct entities, instead of as part of the same story.

And what about the adoption agencies, private nursing homes, maternity hospitals, priests, doctors, and even some prominent Irish names?

What about the baby rackets, the trafficking of children, the thousands of illegal adoptions, the falsification of records? Maybe one day we will get to that.

While we have spent the last year laying flowers at the feet of monuments honouring the dead male Irish heroes of 1916, female heroes lie in graves that are unmarked, forgotten, and largely ignored. Their children lie in other graves, or live, having been adopted, in both Ireland and abroad, many in very dubious circumstances.

This is a history we don’t like to talk about. We have barely written about it.

This is a history in which women who didn’t fit the idealised vision of newly independent Ireland were hidden behind high walls, their children removed from them, boarded out, adopted, or trafficked abroad.

We still don’t know how many were used for medical trials. Thousands more died, while hundreds of infant bodies were used by Irish universities for anatomical research and buried in the Angels’ Plot in Glasnevin as “anatomical subjects”.

The children’s crime? Simply the circumstances of their birth. Their mothers’ crime? That they were unmarried women.

The mistake, now, would be to simply focus on Tuam and the deaths that occurred there. This is a scandal that is as much about the living as it is about the dead.

Very specific concerns about infant mortality in such institutions were raised as early as 1945. The previous year, state inspectors reported that out of 124 infants admitted to the Bessborough home after birth, 102 died — a death rate of 82%.

It briefly led to the government of the day banning pregnant women being sent to the home and led Dr Con Ward to write to then Bishop of Cork, Daniel Cohalan, to express fears about a “public scandal” over the figures.

Our most recent governments fare little better, in terms of institutional knowledge of such shocking infant death rates.

In 2012, senior HSE management was expressing concern at what was being found in relation to both Tuam and Bessborough.

Two reports on the institutions were prepared by the HSE, while it was preparing material for the McAleese investigation into Magdalene Laundries.

These reports not only explicitly reference infant mortality rates, but also express serious concerns about the possible trafficking of children from the institutions. They also mention that these issues needed to be investigated as a matter of urgency.

IN THE case of Tuam, a note of a teleconference call on October 12, 2012, reveals that senior management in the HSE felt what had been discovered warranted a state inquiry.

The call involved then assistant director of the Children and Family Service at the HSE, Phil Garland, and then head of the medical intelligence unit, Davida De La Harpe, expressing concern that 1,000 children had been trafficked from the Tuam mother and baby home in what could “prove to be a scandal that dwarfs other, more recent issues with the Church and State”.

These concerns had been raised by the principal social worker for adoption in HSE West, who had found “a large archive of photographs, documentation, and correspondence relating to children sent for adoption to the USA” and “documentation in relation to discharges and admissions to psychiatric institutions in the Western area”.

The archive contained letters from the Tuam mother and baby home to parents, asking for money for the upkeep of their children, and notes that the duration of stay for children might have been prolonged by the order for financial reasons.

It also contained letters to parents asking for money for the upkeep of some children who had already been discharged or who had died.

The social worker, “working in her own time and on her own dollar”, had compiled a list of “up to 1,000 names”, but said it was “not clear yet whether all of these relate to the ongoing examination of the Magdalene system, or whether they relate to the adoption of children by parents, possibly in the USA”.

Those on the conference call raise the possibility that if there is evidence of trafficking, “it must have been facilitated by doctors, social workers, etc, and a number of these health professionals may still be working in the system”.

The note concludes by stating that, due to the gravity of what was being found, an “early warning letter” be written to the national director of the HSE’s quality and patient safety division, Philip Crowley, suggesting “that this goes all the way up to the minister”.

“It is more important to send this up to the minister as soon as possible: with a view to an inter-departmental committee and a fully fledged, fully resourced forensic investigation and state inquiry,” concludes the note.

A week later, in a separate report sent by Mr Garland to Mr Crowley, and which CC’d then national director of Children and Family Services, Gordon Jeyes, and Ms De la Harpe, Dr Declan McKeown, of the medical intelligence unit, outlines concerns about death rates at both Tuam and Bessborough.

Dr McKeown notes that the infant mortality rate for Tuam was “approximately 20%-25%, similar to that recorded in Bessborough”. He also raised questions as to the veracity of such death rates.

“Queries over the veracity of the records are suggested by causes of death such as ‘marasmus’ in a 2 ½-month-old infant; or ‘pernicious anaemia’ in a four-month-old. These diagnoses would be extremely unusual in children so young, even with the reduced nutrition of the time,” he said.

A separate report into Bessborough not only revealed that the deaths of hundreds of children were recorded in the order’s own register, but that, similar to Tuam, the operation was aimed at making money.

The examination of the order’s own records found that the women and children in its care were “considered little more than a commodity for trade amongst religious orders”.

Minutes from meetings of the Sacred Heart Adoption Society’s board of management “further lend evidence to the order’s preoccupation with materialism, wealth, and social status”, while the wealth and social status of the adoptive parents was often the prime concern when deciding whether they would receive a child.

None of the concerns made it into the McAleese report, as they were outside its terms of remit.

However, that report did include other material that was, “strictly speaking, outside its core remit”, but deemed “in the public interest. This material “may challenge some common perceptions” about Magdalene laundries.

The Report of the Inter-Departmental Group on Mother and Baby Homes, published by the Department of Children and Youth Affairs in July 2014 also failed to mention any of these concerns.

This is despite the fact that two government department’s had seen the 2012 HSE report on Bessborough, which revealed that hundreds of children died at the institution over a 19-year period.

All of the HSE concerns were being raised almost two years before the Tuam babies scandal made international headlines.

Where adoptions fit into all of this should be of particular interest. Adoption campaigners have spent years repeatedly calling for an audit of all adoption records held by the State. So far, these calls have fallen on deaf ears.

It’s hard to understand why. The Adoption Authority informed the government in 2013 that there “may be thousands” of cases where people had their birth history falsified, so they could be illegally adopted. This has never been investigated.

The Department of Children and Youth Affairs was told by an AAI delegation in June, 2013 — more than a year before the mother-and-baby home scandal — that there were “at least 120 [confirmed] cases” of illegal registrations.

This is not a small number, given the small sample size that would have been examined.

However, the AAI went further, stating that this could well be the tip of the iceberg and that there “may be thousands” more. It named a well-known former private nursing home — St Rita’s, in Dublin — where women went to give birth to their children, before having to place them for adoption, as a “huge source of illegal registrations”.

It specifically named one religious-run former adoption agency — St Patrick’s Guild, in Dublin — as being “aware of several hundred illegal registrations”, stating that the agency “are not seeking the people involved”, but were, rather, “waiting for people to contact them”.

The agency’s 13,500 adoption files — one of the largest archives in the country — are now in the hands of Tusla.

In a statement to this newspaper, AAI chief executive, Patricia Carey, said that the ‘may be thousands’ comment made at the meeting was “a throwaway remark” and was “not based on verifiable facts”.

However, the fact that the department had called for a meeting on the subject, and that an AAI delegation was willing to speculate at all on such a large number, indicates that the issue was firmly on the radar of the adoption regulator.

Any woman or adopted person who was through one of the above institutions will not be examined by the current commission, unless her case can be linked to one of the institutions under its remit.

Despite this, and countless media reports of adoptions being contracted on the back of documentation which is as best extremely dubious, the Department of Children and Youth Affairs has stood steadfastly to the line that an audit of adoption records, to ascertain the scale of illegal and forced adoptions, “would yield little useful information”, as there would be “little, if any, supporting information in relation to these arrangements” on the files.

It is impossible to make such a claim without at least examining the records and, secondly, it’s blatantly clear that these records do contain evidence of illegal adoptions.

Adoption support groups have repeatedly said that government refuses to order such an audit, because it fears what will be found. Given what the HSE found in 2012, in relation to Tuam and Bessborough, this may well be the case.

More than one government minister has said, on record, that every adoption carried out by the State since 1952 was done in line with the legislation of the day.

If that level of certainty exists at official levels, then why not open the files, let everyone see them and, for once, have this country do the right thing?

The files of vaccine trial victims in Bessborough Mother and Baby Home were altered in 2002 — just weeks after the Commission to Inquire into Child Abuse sought discovery of records from the order running the home.

Material obtained by the Irish Examiner under Freedom of Information shows that changes were made to the records of mothers and children used in the 1960/61 4-in-1 vaccine trials.

The Commission to Inquire into Child Abuse (CICA) had sought discovery of the records from the Sisters of the Sacred Heart of Jesus and Mary on July 22, 2002. An affidavit was sworn on October 3, 2002, and on a number of later dates in 2002 and 2003.

The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.” The changes made to files Nos 5, 8, 11, 12, and 15 to 20 are then detailed.

The changes include:

The alteration of discharge dates of mothers (by a period of one year and two years);

The changing of discharge dates of children;

The changing of admission dates of mothers;

The alteration of the age of a mother (by two years);

The alteration of dates of adoption;

The changing of baptism dates and location of baptism;

The insertion of certain named locations and information into admission books.

A data protection request released to Bessborough vaccine trial victim Mari Steed in 2011 also confirms this timeline.

A file listing details about both her and her natural mother was created on August 6, 2002. This was done following a request “for Solicitor re Vaccine”. Ms Steed’s natural mother is listed as “No 19 on Doctor’s List”. The record lists “All Counties DUBLIN” above discharge information pertaining to her mother.

The document listing the changes notes that this information was inserted into Ms Steed’s original file.

The entry reads: “No 19 [house name redacted] Crossed out the Indoor Reg entry as it is corssed (sic) out in the Book. Inserted DUBLIN after All Counties.”

Given that the trial took place between December 1960 and November 1961, this change has the effect of placing this woman in Bessborough during the period her child was vaccinated.

If she was, in fact, discharged from Bessborough at the date given in 1960, she could not have been present to consent for her child to have been part of the vaccine trial.

The question of consent was the key issue being examined by the CICA’s Vaccines Module before it was shut down in 2003 following a Supreme Court ruling.

The Irish Examiner put a series of questions to the Sisters of the Sacred Hearts of Jesus and Mary in relation to the document. It declined to answer any of them.

A statement from Ruairí Ó Catháin solicitors, representing the order, stated that it had “no immediate knowledge of any specific event” concerning alterations made to records.

“We are in contact with the commission in regard to the Mother and Baby Homes Investigation, which is having our full co-operation. For the present, as is appropriate, we will be dealing directly with the commission on all related matters,” said a statement.

In a separate statement, the order said it wished to “categorically state that no documents were altered”.

“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer,” said the statement. “This is entirely untrue; and we will continue to deal directly with the official commission on all such matters.”

The Mother and Baby Homes Commission has copied all the records relating to Bessborough and is currently analysing them alongside the other 17 institutions being examined. Its final report is expected in February 2018.

The files of vaccine trial victims in Bessborough Mother and Baby Home were altered in 2002 — just weeks after the Commission to Inquire into Child Abuse sought discovery of records from the order running the home.

Material obtained by the Irish Examiner under Freedom of Information shows that changes were made to the records of mothers and children used in the 1960/61 4-in-1 vaccine trials.
The Commission to Inquire into Child Abuse (CICA) had sought discovery of the records from the Sisters of the Sacred Heart of Jesus and Mary on July 22, 2002. An affidavit was sworn on October 3, 2002, and on a number of later dates in 2002 and 2003.
The document listing the changes opens with: “8.8.02 Checked the 20 files.” This is immediately followed by: “9.8.02 Made the changes.” The changes made to files Nos 5, 8, 11, 12, and 15 to 20 are then detailed.
The changes include:
– The alteration of discharge dates of mothers (by a period of one year and two years);
– The changing of discharge dates of children;

– The changing of admission dates of mothers;

– The alteration of the age of a mother (by two years);

– The alteration of dates of adoption;

– The changing of baptism dates and location of baptism;

– The insertion of certain named locations and information into admission books.

A data protection request released to Bessborough vaccine trial victim Mari Steed in 2011 also confirms this timeline.

A file listing details about both her and her natural mother was created on August 6, 2002. This was done following a request “for Solicitor re Vaccine”. Ms Steed’s natural mother is listed as “No 19 on Doctor’s List”. The record lists “All Counties DUBLIN” above discharge information pertaining to her mother.
The document listing the changes notes that this information was inserted into Ms Steed’s original file.
The entry reads: “No 19 [house name redacted] Crossed out the Indoor Reg entry as it is corssed (sic) out in the Book. Inserted DUBLIN after All Counties.”
Another entry reads: “No 17 [house name redacted] Changed nm [natural mother] disch from x/x/60 to x/x/62”.
Given that the trial took place between December 1960 and November 1961, this change has the effect of placing this woman in Bessborough during the period her child was vaccinated.
If she was, in fact, discharged from Bessborough at the date given in 1960, she could not have been present to consent for her child to have been part of the vaccine trial.
The question of consent was the key issue being examined by the CICA’s Vaccines Module before it was shut down in 2003 following a Supreme Court ruling.

The Irish Examiner put a series of questions to the the Sisters of the Sacred Hearts of Jesus and Mary in relation to the document. It declined to answer any of them.
A statement from Ruairí Ó Catháin solicitors, representing the order, stated that it had “no immediate knowledge of any specific event” concerning alterations made to records.
“We are in contact with the commission in regard to the Mother and Baby Homes Investigation, which is having our full co-operation. For the present, as is appropriate, we will be dealing directly with the commission on all related matters,” said a statement.
In a separate statement, the order said it wished to “categorically state that no documents were altered”.
“In your recent correspondence, you are suggesting that something illegal or inappropriate had occurred in regard to the documents to which you refer,” said the statement. “This is entirely untrue; and we will continue to deal directly with the official commission on all such matters.”

The Mother and Baby Homes Commission has copied all the records relating to Bessborough and is currently analysing them alongside the other 17 institutions being examined. Its final report is expected in February 2018.

The Order which ran the Bessborough Mother and Baby Home has claimed it was instructed in 2013 to destroy “all documents” it held in relation to vaccine trials carried out on children.

The Sisters of the Sacred Hearts of Jesus and Mary made the claim via its solicitors in a letter to Tusla in January 2015 of this year which has been released under Freedom of Information.It said the instruction was issued to them by the Commission to Inquire into Child Abuse (CICA) – which was examining the vaccine trials as part of a separate module until legal action halted the investigation.

It said the instruction was issued to them by the Commission to Inquire into Child Abuse (CICA) – which was examining the vaccine trials as part of a separate module until legal action halted the investigation.

In a statement, the CICA has said it issued “no such instruction” and nor would it do so.

The Order made the claim in response to a letter sent by Assistant Principal Social Worker Pearl Doyle in August 2014 asking a series of questions in relation to material transferred by the Order to Tusla in 2011. The letter was sent as the Government was proposing setting up an investigation into Mother and Baby Homes.

A total of 23 questions were posed concerning infant mortality, burials, financial records and vaccine records.

In relation to vaccine records, Ms Doyle asked the Order where the “complete” list of vaccine records are. She also asked how children were chosen, whether the consent of the mother was obtained and, if so, where these consent forms are.

Responding via its solicitors some five months later, the Order said it had been instructed to destroy “all documents” relating to vaccine trials on the advice of the CICA.

“The Congregation handed over all records held to the HSE. The Congregation were directed by the Commission of Inquiry into the Vaccine Trials in 2013 we believe to destroy all documents in their possession or under their control regarding the trials. That Commission may be in a position to assist you in this regard,” said the letter.

However, the CICA has confirmed it issued “no such instruction”.

“The Commission did not issue any instruction to destroy medical records nor would it do so. The Commission as part of its process of wind down requested the return, or in the alternative certified destruction, of all discovery material issued to the legal representatives of those who were participating and feeding into the investigation.”
“Equally any discovery material sent into the Commission was returned to its original source eg Health Board records supplied to the investigation team under discovery orders were returned to the HSE and material supplied under discovery by other various parties to the investigation were returned to them via their legal representatives,” said a statement.

Mari Steed of Adoption Rights Alliance, herself a victim of vaccine trials as a child at Bessborough, said the revelation was “gravely concerning” stating that if files were destroyed it warranted criminal investigation.

“This is gravely concerning for fellow victims who may not have been able to obtain their records or confirmation that they were part of a trial before they were destroyed. It is an outrage if vaccine records were destroyed and, in my view, this amounts to criminal obstruction of justice. It needs a thorough investigation by the relevant authorities and the Commission.”

Ms Steed, who was adopted to the USA, obtained records of her own participation in the 1960-61 Bessboro vaccine trials prior to 2000 and through a data protection request to GlaxoSmithKline.

The pharmaceutical giant also released a dossier indicating that it had been monitoring statements she had been making to the media on the vaccine trials going back almost a decade.

The scale of use of children for vaccine trials is much greater than was first thought, writes Conall Ó Fátharta

THE latest revelations that another legacy company of pharmaceutical giant GlaxoSmithKline sponsored a fifth, previously undisclosed, medical trial on children in care here in the 1960s needs to result in action from the Government.

The fact is that the picture now emerging is now far more disturbing than that which compelled the then Fianna Fáil-led government to refer the matter for investigation by the Commission to Inquire into Child Abuse (CICA) in 2000.

Before that inquiry was halted following a 2002 Supreme Court ruling, GlaxoSmithKline (GSK) had confirmed just three trials in the 1960s and 1970s using over 250 children. We now know there were at least five trials in this period — the fifth exposed today by the Irish Examiner.

Indeed, recent revelations have shown that, far from carrying out just four vaccine trials on children in care here, Wellcome (now GlaxoSmithKline) sponsored trials in Ireland now span almost half a century — involving dozens of institutions and thousands of children.

The records released to CICA by GSK have now been returned to the company. The commission retained no copies. Yet, no questions have been answered.

Why are victims finding out about new trials now — through the press? Why did the short-lived inquiry not know a fourth and fifth trial had occurred?

Why did the report of Inter-Departmental Group on Mother and Baby Homes published this year still refer only to three vaccine trials — when a fourth was admitted in 2011 and the 1930-1935 trials of a Burroughs Wellcome vaccine for diphtheria carried out on 2,000 children in residential institutions were uncovered by Michael Dwyer of UCC’s School of History just a month before its publication?

Nor did it mention the 1965 trial of a 5-in-1 vaccine carried out on Philip Delaney at Bessborough mother-and-baby home in Cork. Why did this report claim a total of 123 children in institutional settings were used in the first three acknowledged trials when, in fact, 180 children were used?

The revelation that vaccine trials were carried out on children in mother-and-baby homes and other institutional settings first hit the headlines in the early 1990s.

Questions were raised in the Dáil on the subject, but it wasn’t until 1997 that then health minister Brian Cowen gave assurances that the matter would be examined.

In 2000, the Kiely report confirmed that three trials had been conducted on behalf of the pharmaceutical company the Wellcome Foundation. The institutions involved were Wellcome Laboratories in Britain, the Department of Medical Microbiology in UCD, and the Eastern Health Board.

The first trial took place between December 1960 and November 1961 in four Mother and Baby Homes — St Patrick’s on the Navan Road in Dublin (14 children), Bessborough in Cork (25 children), Castlepollard in Westmeath (six children), and Dunboyne (nine children). Four children from Stamullen baby home in Meath were also used for this trial.

The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

The second trial involved 69 children from St Anne’s Industrial School in Booterstown in Dublin being administered an intranasal rubella vaccine. A further 53 children from the wider community in Kilcullen in Westmeath were also used in this trial.

The first two trials were carried out by Professor Irene Hillary and Professor Patrick Meenan from the department of Microbiology in UCD, as well as other doctors.

The third trial involved 53 children in a number of residential institutions in Dublin including St Patrick’s Home, Madonna House, Bird’s Nest, and Boheenaburna. A total of 65 children living at home in Dublin also received the vaccine.

The aim of the third trial was to compare commercially available batches of the 3-in-1 vaccine — Trivax and Trivax D — with that of equivalent vaccines prepared for the trial. There is no published paper or report of this trial, but the Eastern Health Board was aware it was being conducted.

Dr Kiely’s report concluded that, given the reasons which the vaccines sought to counter, the decision to conduct the trials was “acceptable and reasonable”.

However, Dr Kiely said there was a lack of documentation available to clarify whether consent was either obtained or sought from the parents of the children or the managers of the institutions.

However, an entry in the 1962 British Medical Journal concerning the first trial seems to confirm that parental consent was not sought.

“We are indebted to the medical officers in charge of the children’s homes for permission to carry out this investigation on infants under their care,” it wrote.

Responding to the Kiely Report in 2000, Prof Hillary said it was her “invariable practice at the time to obtain consent of the competent authority”, be it the mother, the manager, or the medical officer.

However, no record of written consent has been acknowledged. The religious orders who ran the homes involved in the trials have also denied that they authorised any clinical trials.

Of the victims of the vaccine trials who have located their natural mothers, all mothers have said they were not asked for their permission.

In 2000, then minister for children Micheál Martin admitted the Kiely report was “incomplete” and raised “as many questions as it answered”.

However, despite this, Mr Martin reassured the Dáil that the trials appeared to have had no medically negative consequences for any of the children involved.

In an effort to deal with the matter, the Government decided to extend the terms of reference of the Commission to Inquire into Child Abuse. This was done despite objections that the trials could not adequately be dealt with by an inquiry looking primarily into physical and sexual abuse.

The ‘Vaccines Module’ of CICA began investigating in early 2002. It obtained documentation from GlaxoSmithKline — the successor of Wellcome — and identified the names and addresses of some of those involved in the trials.

However, the probe was hit with a Supreme Court ruling which upheld Prof Meenan’s challenge against a High Court order directing him to give evidence before the inquiry.

The court also criticised the decision to ask the commission to examine the vaccine trials in the first place, stating they had “only the most tenuous connection, if any, with the appalling social evil of the sexual and physical abuse of children in institutions, which was the specific area into which the commission was established to inquire”.

Mr Justice Hardiman stated that Prof Meenan’s involvement in vaccine trials related only to one trial in 1960/61 and that the issue of the “reputational damage” associated with being involved with a Commission primarily looking at sexual abuse had to be considered.

Following this, Prof Hillary challenged the Government’s order directing an investigation into the vaccine trials. The Government did not appeal this decision. As a result, the work of the Vaccines Module’ ceased in November 2003.

However, those who suspected they were victims of the trials continued to claim that there were far more than three trials carried out by Wellcome here.

The Third Interim Report from CICA in December 2003 confirmed as much when it stated that the documentation it received from GSK “disclosed a considerable amount of information in relation to other vaccine trials conducted in the State”.

When RTÉ’s Prime Time asked the pharmaceutical giant about this statement, it confirmed a fourth trial had taken place in 1965. This trial involved giving differing doses of the measles vaccine to 12 babies aged between nine and 19 months in the Sean Ross Abbey mother-and-baby home in Tipperary.

The firm stated that this fourth trial was the only other clinical trial sponsored by Burroughs Wellcome using children in institutions in Ireland.

However, as the Irish Examiner reveals today, a fifth trial also occurred during this period.

An article in The Lancet in August 1965, discovered by Michael Dwyer of UCC’s School of History, confirms that Glaxo Laboratories Ltd carried out yet another measles vaccine trial on 34 children aged between eight months and just over two years. The trial was carried out by Prof Hillary and Prof Meenan of UCD and AJ Beale of Glaxo Laboratories. It is also the first trial which confirms Glaxo Laboratories involvement in a vaccine trial. All of the other trials were carried out by Wellcome.

Although the report does not mention an institution, it makes reference to the fact that the reaction to the children were monitored by “the adults looking after the children”. It also says examinations were done on the children from day six to 14 at the same time — 6pm — indicating the children were in a group setting.

The Irish Examiner put questions to GSK concerning this trial, what institution it was carried out in and why it failed to disclose this trial in 2011.

The company did not agree that the references in The Lancet amounted to evidence that the trial was carried out on children in care, stating that, in other papers by the same investigator, the author explicitly stated that the study was carried out on children in care. GSK said if it had any evidence that this trial was carried out on children in care, it would have handed it over to the CICA.

On the issue of whether consent was either sought or obtained for this study, GSK stated that any studies were done to the highest ethical and safety standards as a fundamental part of developing and delivering new vaccines to treat and prevent illnesses that were a major public health risk at that time.

“The studies of The Wellcome Foundation vaccines were conducted by independent healthcare professionals. The children who participated in the trials were recruited from the community and those living in children’s homes. The methodology and results of at least two of the studies were published in respected journals,” said a statement.

GSK said it had “limited archived documentation” given the trials happened decades ago, but was seeking to investigate the facts. It also confirmed it would fully co-operate with any Government investigation into the issue.

The upcoming Mother and Baby Homes inquiry cannot ignore the issue. Many victims were resident in these homes and deserve answers, justice and all of the information held on them by GSK. Otherwise this state really does view them, even now, as was said in the Dáil in 2000 as “children of a lesser god”.

Vaccine trial confirmed by data request

In 2011, GlaxoSmithKline released a data protection request to vaccine trial victim Mari Steed which confirmed she was part of a vaccine trial it carried out half a century earlier.

It also released a dossier indicating that it had been monitoring statements she had been making to the media on the vaccine trials going back almost a decade.

Ms Steed, who was adopted to the US from Bessborough, discovered she was a victim of the trials in the late 1990s when she was trying to trace her natural mother.

A handwritten note on her medical file released to Ms Steed — the Sacred Heart order then ran the home — confirms she was given three injections for the 4-in-1 vaccine, the third of which was “given by Prof Hillary”. This entry is immediately followed by: “Baby to America.”

Ms Steed’s natural mother Josephine, who passed away last year, always stated that she was never asked for her permission, nor was she aware that vaccines were being trialled on her daughter during her time in Bessborough.

The 4-in-1 trial took place between December 1960 and November 1961 in four mother-and-baby homes. The purpose of the trial was to look at the response the children would have to a 4-in-1 vaccine — diptheria, whooping cough, tetanus, and polio.

Following her data protection request, Ms Steed was astounded to discover that GSK had kept a substantial file on her — and not all of it related to her medical records.

Referred to as “GSK 36” in parts of the documents released to her by the pharmaceutical firm, the records confirm her participation in the trial. However, she was astounded to discover the firm also had a file monitoring media appearances she made talking about the issue.

This included press cuttings from a range of newspaper interviews given by Ms Steed — some almost a decade apart.

Also included were typed transcripts from a number of different radio interviews. These included an interview with PJ Coogan on Cork radio station 96FM and an extract from a news bulletin on the station where she was quoted.

Ms Steed said the fact that the pharmaceutical giant was monitoring her public statements was “shocking”, although “not entirely surprising”.

“It was somewhat shocking to realise that GSK had been keeping such data on me, although not entirely surprising,” she says. “Just prior to receiving my DPA reply from GSK, I had received my entire file from the HSE South, which included a six-page dossier that Sister Sarto of Bessborough had kept on me, noting similar media references and untoward comments regarding my search for my mother.”

Ms Steed said she was aware of a number of Bessborough adoptees who had made DPA requests from GSK, but said she was not aware of anyone else that has had their participation in a vaccine trial formally confirmed by the company.

“I personally know one individual who came forward as part of the initial Laffoy investigation, but has not filed a request under DPA as far as I know; and of course, one other who participated in the Prime Time investigation,” says Ms Steed. “Many more have unexplained marks and scarring on their bodies, including outside areas where vaccines would typically be given.

“And every person I know, among hundreds, who were adopted from Ireland to the US, reported that as children we all came up as testing positive for TB during routine childhood doctor visits, despite not actually suffering from it. This anomaly has never been able to be explained by our family practitioners here in the US.”

The Philadelphia woman said the fact that the vaccine issue has never been fully investigated defied belief, and said many US adoptees were considering going to the courts unless the issue was included in the upcoming Mother and Baby Home inquiry.

“Failing that, I believe there are enough of us to move forward through the courts on the matter, including the EU court and potentially the UN,” says Ms Steed.

“There seems to be an inexplicable reluctance on the part of the Irish legal community to represent victims of such trials and proceed with cases. Although we are now making inroads to US law firms who have handled legal cases against GlaxoSmithKline and may be willing to provide representation.”

Waiting for some answers

Mari Steed is one of the few people that knows she was used in a vaccine trial. Others are not so lucky.

For people such as Christopher Kirwan, the wait for answers goes on.

He has written to numerous ministers of children to no avail. He has also written to GSK and to the Sacred Heart Sister — both of which have told him he was not used in any vaccine trial carried out in Bessborough.

A investigation by the Data Protection Commissioner in 2011 also confirmed that neither GSK nor the records then held at Bessborough indicated that he was part of a vaccine trial. That would be fine if the Cork man didn’t have eight unexplained scars on his arms and legs.

Mr Kirwan was born in Bessborough in November 1960 and was adopted the following June. He was in Bessborough during the period of the first Burroughs Wellcome vaccine trial, and even had his photo taken with Mari Steed as a baby.

Despite his scars, his records simply state that he was inoculated for the BCG and smallpox and that no documentation indicating he was part of those trials.

Mr Kirwan believes he was involved in a vaccine trial of some form as the marks on his body do not make sense for someone who just received two inoculations. His adoptive mother told him that when he left Bessborough as a child he had bandages on his arms. “I just want answers,” he says.

Philip Delaney has also been told he was not part of any vaccine trial, despite his medical records indicating he was give three injections of a 5-in-1 vaccine for polio, measles, diptheria, whooping cough, and tetanus. Beneath the record showing this injection, the words “Contact Dr Hillary, Dublin” are crossed out.

His adoptive mother told Prime Time in 2011 that she was told by a doctor who came to take the blood in a follow-up visit that Mr Delaney was one of 20 babies used for a trial for a 5-in-1 vaccine and that the babies were not supposed to have been given up for adoption.

“The Government are saying there have been no ill effects,” says Mr Delaney. “How do they know? Because they don’t know about this trial.”